Method for treating migraine symptoms with ibuprofen and salts thereof

#The present invention relates to the treatment of migraine symptoms by the administration of an effective amount of ibuprofen, more specifically the present invention relates to the treatment of phonophobia and photophobia with ibuprofen.

#Migraine provides a wide variation of pain and symptoms, and associated disorders with those who suffer from the disease. Included among these symptoms are nausea, headache, moderate to severe pain, as well as incapacitating pain and total disability in a percentage of patients. Some patients also recite more specific symptoms such as photophobia, painful sensitivity to light; or phonophobia, painful sensitivity to sound.

#Treatment of migraine pain includes both prescription and non-prescription or over-the-counter medication. Among the over-counter medication that is currently available is a combination of acetaminophen/aspirin/caffeine, as set forth in U.S. Pat. No. 5,972,916, the contents hereby incorporated by reference as set forth herein in its entirety. The combination of active ingredients suffers from the drawback that some of the actives might cause undesired side effects. For example, it is well know that aspirin can cause stomach irritation and caffeine can cause anxiety and sleeplessness.

#FIG. 1 depicts the percentage of subjects with reduced photophobia over time after treatment with ibuprofen.

#FIG. 2 depicts the percentage of subjects with reduced phonophobia over time over time after treatment with ibuprofen.

#Ibuprofen is a well known analgesic material that has analgesic and antipyrritic properties. It is commercially available in various forms for many years.

#According to the present invention, ibuprofen, pharmaceutically acceptable salts thereof, isomers thereof, or mixtures thereof, are preferably administered as an oral dose, as an effective dose to alleviate the photophobia and phonophobia symptoms, which comprises from about 100 to about 800 milligrams of ibuprofen per dose; preferably from 200 to about 600 and most preferably from about 300 to about 400 milligrams of ibuprofen per dose. Typical doses of the pharmaceutically acceptable salts of ibuprofen will vary according to the molecular weight of the salt required to give the equivalent dose of ibuprofen. Typical oral doses of pharmaceutically acceptable salts of ibuprofen range from about 110 to about 1700 milligrams per dose. Typical doeses of mixtures of ibuprofen or its isomers with pharmaceutically acceptable salts thereof range from about 100 to about 1700 milligrams per dose, preferably from about 200 to about 1300 milligrams per dose, and most preferably from about 300 to about 850 milligrams per dose. Typically doses are taken every four to six hours, but care should be taken to avoid exceeding the daily maximum recommended dosage of ibuprofen of 2400 milligrams per day.

#Examples of suitable pharmaceutically acceptable salts of ibuprofen include any of the inorganic cation salts such as sodium, potassium, lithium, magnesium, calcium, cesium, ammonia, ferrous, zinc, manganous, aluminum, ferric, and manganic; organic salts of ibuprofen with primary, secondary, tertiary and quaternary amines, or mixtures thereof. Examples of such primary, secondary, tertiary and quaternary amines include substituted amines including but not limited to naturally occurring substituted amines, cyclic amines, basic ion exchange resins, and mixtures thereof. More specifically, suitable amines include but are not limited to triethylamine, tripropylamine, 2-dimethylaminoethanol, 2-diethylaminoethanol, lysine, arginine, histidine, caffeine, procain, N-ethylpiperidine, hydrabamine, choline, betaine, ethylenediamine, glucosamine, TRIS(hydroxymethyl)aminomethane, methylglycamine, theobromine, pruines, piperazine, piperidine, polyamine resins and the like, and mixtures thereof. In one embodiment, a mixture of ibuprofen and its sodium salt may be used.